FDA 510(k)

INDUO BLOOD GLUCOSE METER

K-Number: K011616 · 2001-06-21

ApplicantInverness Medical Innovations, Inc.

Decision Date2001-06-21

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

INDUO BLOOD GLUCOSE METER is the device name listed in this FDA 510(k) record. The listed applicant is Inverness Medical Innovations, Inc.. It received FDA 510(k) clearance on 2001-06-21 under 510(k) number K011616. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INDUO BLOOD GLUCOSE METER?

INDUO BLOOD GLUCOSE METER is a medical device that received FDA 510(k) clearance on 2001-06-21. The listed applicant is Inverness Medical Innovations, Inc.. The 510(k) number is K011616.

When did INDUO BLOOD GLUCOSE METER receive FDA 510(k) clearance?

INDUO BLOOD GLUCOSE METER received FDA 510(k) clearance on 2001-06-21, under 510(k) number K011616.

Who is the listed applicant for INDUO BLOOD GLUCOSE METER?

The FDA 510(k) record lists Inverness Medical Innovations, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INDUO BLOOD GLUCOSE METER?

The FDA product code for INDUO BLOOD GLUCOSE METER is NBW. This falls under the OB/GYN category.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.